Parkinson Disease
Conditions
Keywords
PD, Parkinson's, Parkinson's Disease, Microbiome
Brief summary
The purpose of this study is to evaluate the microbiome of medicated and non-medicated subjects diagnosed with Parkinson's disease. Where available, in comparison to the microbiome of a healthy spouse or 1st degree relative.
Detailed description
First, a cross sectional study where the investigators will compare microbiome composition in subsets of PD and Multiple System Atrophy (MSA) patients whose household control agree to provide stool samples as well. Each household control subject will be evaluated to ensure there is no clinical evidence of neurological disorders including PD. Also, these subjects will complete a 24 hour diet recall questionnaire before stool collection and validated 3 month food frequency questionnaire to collect dietary information similar to PD patients. Each subject (including PD subjects) will complete a smell questionnaire and a sleep questionnaire to determine whether these control subjects have loss of smell or have REM sleep disorders because these conditions increase the risk of PD. For assessing smell, investigators will use the UPSIT questionnaire. For assessing REM sleep disorder, investigators will use RBD1Q which consists of a single question, answered yes or no, as follows: Has the subject ever been told, or suspected themselves that they seem to 'act out their dreams' while asleep (for example, punching, flailing their arms in the air, making running movements, etc.)? Second, in the longitudinal study, the investigators will collect stool every 3 months with 3 day diet questionnaire prior to each collection over 12 months and determine microbiome composition over time. Investigators will correlate the microbiome data with PD symptoms, diet and response to treatment and progression of disease. These studies will determine whether disease progression and factors such as PD medications and diet significantly impact microbiome composition. Furthermore, the investigators will determine whether changes in SCFA-producing bacteria and/or abnormal SCFA profiles correlate with severity of PD symptoms.
Interventions
None listed
Sponsors
California Institute of Technology
Purdue University
Rush University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
PD Subjects Inclusion: * 40-80 years of age * Previously diagnosed with Parkinson's disease * Parkinson's disease stage between 1-4 * Are willing to participate in the study Healthy control/ Spouse/ 1st degree relative Inclusion: * Adults 40-80 years of age * No clinical evidence of neurological disorders including Parkinson's disease * Live in the same household as the Parkinson Disease patient or is a first degree relative of the PD patient or an independent healthy control * Are willing to participate in the study
Exclusion criteria
PD Subjects Exclusion: * History of GI diseases (except for hemorrhoids or occasional (\<3 times a week) heartburn) like Inflammatory bowel disease or Celiac disease. * Antibiotic use within last 12 weeks. * Use of probiotic supplement except yogurt. * Intentional change in diet. * Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed. Healthy control/ Spouse/ 1st degree relative Exclusion: * History of GI diseases (except for hemorrhoids or occasional (\<3 times a week) heartburn) like Inflammatory bowel disease or Celiac disease. * Antibiotic use within last 12 weeks. * Use of probiotic supplement except yogurt. * Intentional change in diet. * Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study microbiome composition to explain the exact nature of the dysbiosis (microbial imbalance) | 4 years | The investigators anticipate confirming their prior findings that patients with PD have dysbiosis, and further identifying the nature of the dysbiosis including changes at the species and strain level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify the potential contributing factors for dysbiosis in PD | 4 years | It is well established that environmental factors such as diet, as well as genetics, impact microbiome composition.Currently, there are no data for how environment impacts the microbiome in PD. |
| Determine how dysbiosis promotes PD | 4 years | The investigators will determine SCFA (Short chain fatty acids) concentrations in serum and stool from early onset PD patients and healthy controls. The investigators will correlate serum, stool data, PD symptoms and disease severity obtained through validated PD questionnaires. |
Countries
United States
Outcome results
None listed